APEX ARC HIP STEM

K090845 · Omni Life Science, Inc. · LZO · Apr 7, 2010 · Orthopedic

Device Facts

• Record ID: K090845
• Device Name: APEX ARC HIP STEM
• Applicant: Omni Life Science, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Apr 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apex ARC™ Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur.

Device Story

Apex ARC Hip Stem is a modular femoral component for total hip arthroplasty; used in primary or revision procedures. Device comprises a curved, rectangular tapered titanium alloy stem and modular cobalt chromium necks; necks offer neutral, 8-degree, or 12-degree varus-valgus angles. System is compatible with existing Apex Modular and Apex K2 hip system heads and acetabular cups. Surgeons select component combinations to match patient anatomy. Device provides uncemented fixation via plasma-sprayed commercially pure titanium porous coating; hydroxyapatite overcoat is optional. Used in clinical settings by orthopedic surgeons to restore joint function and alleviate pain associated with degenerative disease, fractures, or deformities.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, including distal and proximal fatigue strength (ISO 7206-4/6/8, ASTM 2068-09), fretting potential (ISO 17853), disassembly strength (ASTM F2009), torsional strength, range of motion (ISO 21535), and burst/rotational stability testing for the modular neck-ceramic head combination.

Technological Characteristics

Materials: Ti6Al4V titanium alloy stem, cobalt chromium modular necks, CP Ti plasma-sprayed porous coating, optional hydroxyapatite overcoat. Design: Curved, rectangular tapered stem with distal slots. Modular components allow for variable neck angles (neutral, 8°, 12°). Standards: ISO 7206 series, ASTM F2068-09, ISO 17853, ASTM F2009-00, ISO 21535, ISO 7206-10. Sterilization: ETO (ANSI/AAMI/ISO 10993-7).

Indications for Use

Indicated for patients requiring primary or revision total hip replacement via uncemented fixation. Conditions include non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, congenital dislocation, revision procedures, and femoral neck/trochanteric fractures.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Apex K2 (K041950)
• Aesculap Metha (K071916)
• Aesculap Metha (K083495)

Reference Devices

• Apex Modular (K000788)
• Apex Modular (K012918)
• Apex Modular (K073150)
• Apex Modular Acetabular Cup (K031110)
• Apex Modular Acetabular Cup (K062489)
• Apex Modular Acetabular Cup (K073150)
• Hydroxyapatite coating (K043123)

Submission Summary (Full Text)

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## 510(K) Summary K090845

## Apex ARC™ Hip Stem

# April 7, 2010

| 1.Submitter | OMNI life science, Inc<br>50 O'Connell Way<br>E. Taunton, MA 02718 |
|-------------|--------------------------------------------------------------------|
| Contact: | Robert Zoletti<br>VP Regulatory Affairs<br>774-226-1845 |

| 2. Device Name | Apex ADCM Hip Stem |
|----------------|--------------------|
|----------------|--------------------|

| Proprietary Name: | Apex ARC ^TM Hip Stem |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Hip prosthesis, uncemented |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis |
| Regulatory Class: | Class II per 21 CFR §888.3353 and §888.3358 |
| Product Codes: | LZO, MEH, and LPH |
| 3. Legally Marketed Predicate Device | K041950 - Apex K2, K071946, K083495 - Aesculap Metha® |
| 4. Device Description | The Apex ARC Hip Stem consists of a curved, rectangular tapered stem, and modular necks that connect to the tapered hole in the stem. The femoral stems are manufactured from titanium alloy and the modular necks are manufactured from cobalt chromium alloy. Three neck sizes are offered, with a neutral, 8 degree, and 12 degree varus-valgus angle, respectively. The necks are compatible with the modular heads that are part of the Apex Modular and Apex K2 hip systems (K000788, K012918, and K073150) and may be used with head diameters and offsets up to a maximum offset of +7 mm. These configurations allow the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The Apex ARC Hip Stem may be used in conjunction with the Apex Modular™ Acetabular Cup (K031110, K062489, and K073150) for total hip arthroplasty. |
| 5. Intended Use | The Apex ARC™ Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: <ul><li>Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;</li><li>Rheumatoid arthritis;</li><li>Correction of functional deformity;</li><li>Congenital dislocation;</li><li>Revision procedures where other treatments or devices have failed;</li><li>Femoral neck and trochanteric fractures of the proximal femur.</li></ul> |
| 6. Predicate Device Comparison | Substantial equivalence is claimed to the Apex K2™ Hip System (distributed by OMNI life science, Inc.) and the Metha® Hip System (distributed by Aesculap Implant Systems, Inc.). The table below compares the features and characteristics of the Apex ARC Hip Stem to these predicate devices: |

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#### 510(K) Summary K090845

Image /page/1/Picture/1 description: The image shows the logo for Omni Life Science. The logo features a stylized eye-like symbol above the company name. The eye symbol is composed of concentric circles, with the innermost circle being white and the outer circles being black. The text "OMNI life science" is written in a bold, sans-serif font below the eye symbol.

| | Apex ARC™ | Apex K2™ | Aesculap Metha® |
|-------------------------------------------------------|-------------------------------|-------------------------------|-------------------------------|
| FDA 510(k)'s | | K041950 | K071916 and K083495 |
| INTENDED USE | | | |
| Primary and revision hip replacement,<br>non-cemented | Yes | Yes | Yes |
| DESIGN | | | |
| Circumferential porous coating | Yes - plasma<br>sprayed CP Ti | Yes - plasma<br>sprayed CP Ti | Yes - plasma sprayed<br>CP Ti |
| Proximal coating (only) | Yes | Yes | Yes |
| Modular head | Yes | Yes | Yes |
| Modular neck | Yes | Yes | Yes |
| Tapered stem | Yes | Yes | Yes |
| Cross-sectional shape | Rectangular | Rectangular | Rectangular/ rounded |
| Distal slot(s) | Yes | No | No |
| Distal flutes | No | No | No |
| MATERIALS | | | |
| Titanium alloy (Ti6Al4V) stem | Yes | Yes | Yes |
| Cobalt chromium modular neck | Yes | No - titanium alloy | Yes |
| Cobalt chromium or alumina ceramic<br>heads | Yes (both) | Yes (both) | Yes (both) |
| Titanium porous coating | Yes - unalloyed | Yes - unalloyed | Yes - unalloyed |
| Hydroxyapatite overcoat option | Yes | No | Yes - calcium<br>phosphate |

The most significant difference between these devices is that the subject Apex ARC hip stem and the predicate Aesculap Metha hip stem both employ cobalt chromium modular necks with a tapered junction between the neck and the stem, whereas the Apex K2 stem system employs titanium alloy modular necks with a cylindrical press-fit junction and alignment pin.

7. Non-Clinical Test Summary The following tests were conducted:

- Distal fatigue strength per ISO 7206-4:1989, ISO 7206-8:1992, and ASTM 2068-. 09.
- Fretting potential per ISO 17853:2003. .
- Disassembly strength after fatigue testing per ASTM F2009-00. .
- Proximal fatigue strength per ISO 7206-6:1992 and ASTM 2068-09. .
- Torsional strength of the modular neck. .
- Range of motion per ISO 21535:2007. .
- Burst test, fatigue test, post-fatigue burst test, pull-off, and rotational stability of . the worst case modular neck-ceramic head combination per FDA Guidance for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems, and ISO 7206-10:2003.
- ETO Residuals per ANSI/AAMI/ISO 10993-7. .
- The Hydroxyapatite coating was previously cleared in K043123 .

8. Clinical Test No clinical studies were performed. Summary

The Apex ARC™ is substantially equivalent to the predicate devices. 9. Conclusions Nonclinical and Clinical

OMNI Apex ARC

K090845-S3-Page 1 of 2

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Image /page/2/Picture/12 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

OMNI life science, Inc. % Mr. Robert Zoletti · Vice President Regulatory Affairs 50 O'Connell Way E. Taunton, Massachusetts 02718

APR - 7 2010

Re: K090845 Trade/Device Name: - Apex ARCTM Hip Stem Regulation Number: 21 CFR 8888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prothesis Regulatory Class: II Product Code: LZO, MEH, LPH Dated: March 31, 2010 Received: April 1, 2010

Dear Mr. Zoletti:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misJeading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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#### Page 2 - Mr. Robert Zoletti

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, plcasc note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Millman

Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K090845

Device Name: Apex ARC™ Hip Stem

Indications For Use:

The Apex ARC Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:

- Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis;
- . Rheumatoid arthritis;
- Correction of functional deformity; .
- Congenital dislocation: .
- Revision procedures where other treatments or devices have failed; .
- Femoral neck and trochanteric fractures of the proximal femur. .

Prescription Use X

AND/OR

(Per 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anta for mxn

(Dision Sien-Off) Division of Surgical, Orthopedic, and Resprative Devices

510(k) Number K900845

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